Evidence map›Paper›PMID 41054443›Full record

ArticleEClinicalMedicine2025

Long-term safety of mid-urethral sling for stress urinary incontinence in women: an emulated trial using French national health data system.

Cyrille Guillot-Tantay, Sylvie Guillo, Minh Hoang Thuy Diep Tran, Yann de Rycke, Agnès Dechartres, Pierre Mozer, Emmanuel Chartier-Kastler, Florence Tubach

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Cyrille Guillot-TantayHôpital Foch, Service d'urologie et de transplantation rénale, F92150, Suresnes, France.
Sylvie GuilloSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Équipe PEPITES, F75013, Paris, France.
Minh Hoang Thuy Diep TranSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Équipe PEPITES, F75013, Paris, France.
Yann de RyckeSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Équipe PEPITES, F75013, Paris, France.
Agnès DechartresSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Équipe PEPITES, F75013, Paris, France.
Pierre MozerSorbonne Université, Hôpital Pitié Salpêtrière, Service d'urologie, AP-HP, F75013, Paris, France.
Emmanuel Chartier-KastlerSorbonne Université, Hôpital Pitié Salpêtrière, Service d'urologie, AP-HP, F75013, Paris, France.
Florence TubachSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Équipe PEPITES, F75013, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Mid-urethral sling (MUS) is the most-indicated therapy for treating stress urinary incontinence (SUI) in women. However, serious long-term side effects have escaped post-marketing studies. We aimed to compare two different MUS types, tension-free vaginal tape (TVT) and trans-obturator tape (TOT), in terms of incidence of MUS removal or section after implantation. Methods: We emulated a hypothetical target trial using French national healthcare data (SNDS) and included women who had undergone a first MUS implantation from 2011 to 2018 (Health Data Hub registration no. T16166982020061). The primary outcome was the cumulative incidence of MUS removal or section. Secondary outcomes were the cumulative incidence of MUS removal and section, hospitalization for urinary retention and MUS erosion and infection, and any of these outcomes, as well as reoperation for SUI. We used propensity score-weighted Cox models. Findings: In all, 215,141 women underwent implantation: 170,781 (79.4%) with TOT and 44,360 (20.6%) with TVT. At 5 years, the weighted cumulative incidence of MUS removal or section was lower in the TOT than TVT group (3.25%, 95% confidence interval CI 3.16-3.34 versus 4.13%, 95% CI 3.94-4.33). We observed a time-varying effect ([0-3 months] after implantation [hazard ratio 1.65, 95% CI 1.52-1.78], [3-12 months] after implantation [1.19, 95% CI 1.06-1.32], [1-5 years] after implantation [0.98, 95% CI 0.88-1.1] and ≥5 years after implantation [1.44, 95% CI 1.13-1.85]). MUS removal and section and hospitalization for urinary retention and MUS erosion and infection were significantly more frequent in women with TVT than TOT but second MUS implantation for SUI recurrence was less frequent. Interpretation: The risk of MUS removal or section was higher after TVT than TOT, with a time-varying effect, in this hypothetical target trial. Funding: This study was funded by a grant from the French Ministry of Health.

Indexed as

Mid urethral slingsSafetyStress urinary incontinenceTarget trial emulationUrinary incontinence

Identifiers

PMID41054443
PMCPMC12496164

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.